New! RSV Antibody for Preventing Severe Infection in Infants Approved by the FDA.

Lower respiratory tract infections caused by respiratory syncytial virus, or RSV, sends thousands of babies to the hospital every year. The U.S. Food and Drug Administration approved a new drug-a monoclonal antibody called nirsevimab-that protects infants from severe RSV infections. Nirsevimab is the second antibody to be approved in the U.S. for this purpose, though, compared to the other option, confers longer-lasting protection with a single dose and has been approved for use in a broader range of infants.
But how-and how well-does this new antibody work? When will it become available for clinical use? What other tools are being developed to prevent severe RSV infections as the next RSV season looms large?
RSV is the most common cause of severe lower respiratory tract disease in infants. And there is an antibody (palivizumab) that keeps high-risk babies out of the hospital about 50% of the time. The short half-life of this antibody, however, means it must be administered monthly during the RSV season. Nirsevimab, the latest antibody to be approved by the FDA, reduces risk of medically attended RSV lower respiratory tract disease by about 70%, and requires only 1 injection for the RSV season. It has been approved for a broader range of infants, though we do not yet know the recommendations for which infants it will be specifically used for. Finally, additional preventive tactics, including maternal RSV vaccines, are also on the horizon, which would further expand options for protecting babies from severe RSV infection.
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